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To compare the efficacy and safety of adding once – daily basal Glargine insulin
versus switching to twice – daily premixed insulin in Type-II diabetic patients not well controlled
by combined oral antidiabetic agents.
Methods: In a 6 months parallel group clinical trail on 221 patients with Type-II diabetes and
poorly controlled on oral antidiabetic agents (fasting blood glucose > 140 mg/ dl and glycosylated
hemoglobin >8%) on oral antidiabetic treatment (metformin plus sulfonylurea) were randomized
either to add Glargine insulin or to shift them to mixed insulin (30% regular insulin and 70% NPH)
twice per day without oral antidiabetic treatment. Insulin dosage was titrated to target fasting
blood glucose < 100 mg/dl and predinner blood glucose < 120 mg /dl.
Results: Mean hemoglobin A C decrease from baseline was significantly pronounced (- 2.1 vs. -
1.3 % p = <0.005), and more patients reached HbA C <7% (57 vs. 31%) with Glargine insulin plus oral antidiabetic treatment than with mixed insulin. The number of patients who achieved the
target of fasting blood glucose < 100 mg/dl were more in the group which received Glargine
insulin than the other group that received mixed insulin (41.7 vs. 17.8 %).
Conclusions: Initiation of insulin therapy in patients with Type-II diabetes uncontrolled on com-
bined metformin and sulfonylurea by adding Glargine insulin was more effective than starting
with twice daily of mixed insulin (30% regular insulin and 70% NPH insulin).
KEYWORDS: Type-II diabetes, insulin, Glargine insulin.
Pak J Med Sci January-March 2006 Vol. 22 No. 1 14-17 INTRODUCTION
that near normal blood glucose concentrations Treatment of patients with Type-II diabetes markedly reduce the microvascular complica- mellitus includes education, exercise, diet con- tion.1 The American Diabetes Association rec- trol and medication. The medication available ommends that the objective of normalizing gly- for treatment of Type-II diabetes stimulate beta cemia and glycosylated hemoglobin concentra- cell to secret insulin or these drugs increase the tions for patients with Type-II diabetes should sensitivity of the insulin. The optimal level of be similar to that for Type-I diabetes.2 Most of glycemic control in patients with Type-II dia- the patients with Type-II diabetes failed to betes is becoming clear. The United Kingdom achieve the glycemic goals by diet, exercise, and Prospective Study of diabetes demonstrated combined oral antidiabetic agents. They needeither addition or shifting them to exogenous insulin, for better glycemic control. We used to Medical Department,King Abdul Aziz University Hospital, shift them to twice daily mixed insulin but af- ter availability of Glargine insulin we started to added it to the combined oral antidiabetic agents. The objective of this study was to find the efficacy of adding Glargine insulin to Type- II diabetes insufficiently controlled by oral agents in comparisons to twice daily mixed 14 Pak J Med Sci 2006 Vol. 22 No. 1
monthly for a total of six months. In each visit, Two hundred and twenty one patients diag- fasting blood glucose and postprandial blood glucose were obtained. The vital signs, neuro- equately controlled by combined oral antidia- logical examination, cardiovascular examina- betic agents were included in the study. They tion and the weight were documented every were treated by maximum dose of metformin month. The glycosylated hemoglobin and se- and sulfonylureas for at least 3 months. They rum lipids profiles were done in the beginning were followed at the endocrinology clinic at and then after every 3 months. SSPP 10 was Jeddah city Saudia Arabia. DSFH is one of the biggest private hospitals in Jeddah city. It is A total of 221 patents were included in this very busy hospital with more than 350 beds.
study and all completed the six month follow The out patients endocrine clinic in DSFH is up. There age was from 43 – 70 years (56.3). It very busy clinic with more than 40 patients included 97 female and 124 male. One hun- daily. We applied the ADA standard care of dred and eleven patients received Glargine in- diabetes, and aimed to achieve their recom- sulin in addition to the combined oral antidia- mended goals in treatment of diabetes. Fast- betic drugs, while 110 patients were shifted ing blood glucose, postprandial blood glucose, completely to mixed insulin. The highest dose fasting serum lipids, and glycosylated hemo- of Glargine insulin given was 60 units, with globin was done in all our patients suffering mean dose 40 units. In mixed insulin we in- from diabetes and repeated in follow up. The creased the dose up to 120 units (mean 60 patients included in our study were having Glargine insulin were more than140 with mean fasting blood glucose more than 140 mg/dl.
187 mg/dl but after treatment it was between 95 – 155mg/dl with mean 103 mg/dl. Eighty agreed to be included in the study. The patients three patients achieved the required fasting weltering from chronic renal failure, severe blood sugar. The glycosylated hemoglobin be- cardiac disease and elderly patients (age >70 fore Glargine insulin was 8 – 16.4% with mean years), were excluded from the study. They 11.4% and after treatment it decreased to 8.7%.
were divided into two groups. In one group Patients treated with mixed insulin showed Glargine insulin was added while patients in improvement of blood glucose from the mean the other group were put on mixed insulin level of 183 to 133mg/dl, and the glycosylated (30% regular insulin and 70% NPH). The start- hemoglobin improved from 11.2% to 9.8%. The ing dose of Glargine insulin was 14 units per day titrated up weekly according to the fast- 2.7% in patients treated by Glargine insulin ing blood glucose levels. Fasting blood glucose and in patients treated by mixed insulin by 1.4% was more than 200 mg/dl. The dose was in- creased by 8 units. In case of less than 200 and Mean weight of patient in both groups was more than 140 mg/dl the dose was increased 67.3 kg and it increased after treatments. In by 4 units per week. The doses of mixed insu- Glargine insulin group the mean weight in- lin were one unit per kg in the beginning di- creased by 3.4 kg, whereas in the other group, vided to two third in the morning and one third it increased by 7.3 kg. (p-value = <0.005).
creased weekly by 4 units if the postprandial DISCUSSION
level was more than 200 mg/dl and the evening dose was increased by 4 units if the fasting blood glucose was more than 140 mg/dl. They normoglycemia is now the goal for many, if were followed weekly in the first month then not most of the patients with Type-II diabetes.
Pak J Med Sci 2006 Vol. 22 No. 1 15
Initial treatment should begin with diet, weight slightly less nocturnal hypoglycemia, albeit at greater cost.13 The optimal timing of once – normoglycemia if compliance is optimal. Pa- daily NPH is at bed time, while morning ad- tients with persistent hyperglycemia are typi- ministration of insulin Glargine appears to be cally started on one or more oral hypoglycemics.
Insulin has traditionally been used only if in- adequate control persists despite use of these without continuation of oral drugs. This ap- proach is cheaper than combined therapy but The therapeutic options for patients who fail results in more weight gain and more episodes initial therapy with combination of oral hy- of hypoglycemia.1 Adding Glargine insulin poglycemic drugs are either to add insulin or to discontinue the drugs and switch to insulin.
agents was safer and more effective than be- Part of the rationale for combining an oral hy- ginning twice daily injections and discontinu- poglycemic drug with insulin therapy is that ation oral antihyperglycemic drugs.15 Our insulin can suppress hepatic glucose output, study showed similar result as regards efficacy the primary cause of fasting hyperglycemia.3 of Glargine insulin with oral antiglycemic drugs than twice daily mixed insulin.
several randomized placebo – controlled trails of combination therapy reveal modest but con- REFERENCES
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